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The Impact of a Dermatology Information Source on Skin Problem Outcomes in Primary Care

Primary Purpose

Decision Support Systems,Clinical, Skin Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VisualDx
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Decision Support Systems,Clinical focused on measuring Clinical Knowledge Systems, Decision support, Dermatology, Technology Assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients seen by a participating Primary Care Provider for a chronic or acute skin problem

Exclusion Criteria:

  • Skin problems due to burns or lacerations
  • Cognitively impaired, mentally ill, prisoners, non-English speaking

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention - VisualDx Arm

    Control - Usual Care Arm

    Arm Description

    Arm had 2 levels: provider (cluster) level and patient level. Providers, randomly assigned to the intervention arm, refer to VisualDx when they saw a patient who presented with a skin problem. Their patients were assigned to the intervention group and interviewed about the outcomes of their treatment.

    Arm had 2 levels: provider (cluster) level and patient level. Providers, randomly assigned to control, did not refer to VisualDx but could refer to other information sources or none per usual care. Their patients were assigned to the control group and interviewed about the outcomes of their treatment

    Outcomes

    Primary Outcome Measures

    Number of Patients With Resolved Skin Problems
    Resolved skin disease status was assessed by phone interview. Patient reported status. Patients were censored if "unresolved" at 90 days.
    Number of Follow-Up Visits to Any Provider for the Same Problem
    Follow-up visits count is assessed at each phone interview. Patients report return visits.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 29, 2016
    Last Updated
    July 29, 2019
    Sponsor
    University of Vermont
    Collaborators
    University of Vermont Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02922738
    Brief Title
    The Impact of a Dermatology Information Source on Skin Problem Outcomes in Primary Care
    Official Title
    The Impact of a Dermatology Information Source on Skin Problem Outcomes in Primary Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    November 15, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Vermont
    Collaborators
    University of Vermont Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Health care providers use a variety of computerized medical information sources to reduce knowledge gaps and support patient care decisions. Few studies have evaluated the impact of medical information sources on patient outcomes. Skin problems are the reason for many visits to primary care providers and result in a high percentage of referrals to dermatologists and return visits to primary care for the same skin problem. The objective is to evaluate the impact of primary care providers' use of a dermatology information source, VisualDx, on skin problems outcomes. The study design is a cluster-randomized controlled trial. Participants include primary care providers as clusters and their patients with skin problems. Providers are randomized to intervention group that refers to VisualDx when seeing a patient with a skin problem, or to the control group who does not. Patients have the randomized group status of the doctor they saw for the problem. Patients are interviewed to determine the problem status and how many follow-up visits they had for the problem at intervals after the index visit.
    Detailed Description
    The research design is a cluster randomized controlled trial of a computerized dermatology information source. This is a two-level design in which primary care providers (PCPs) who see patients for skin problems are the subjects of randomization. Their patients are the subjects of the data collection and analysis. The cluster design examines how much variation in the outcomes is attributable to the providers, how much to patients within the clusters, and how much to the intervention information source itself. Provider Level: After completing a baseline questionnaire, providers are randomized to intervention or control groups. Intervention group providers have an orientation to the study protocol that includes how to access and use VisualDx. Control providers receive the protocol overview, but no orientation to the intervention. Intervention providers agree to refer to VisualDx content when they have a patient with a skin complaint. Control group providers agree not use VisualDx as a reference but may use another medical information source or none. Patient Level: To identify eligible patients, authorized investigators reviewed information from the patient record sufficient to send a letter to them over the provider's signature to notify them about the study. The letter gives the option to refuse any contact. At 30 days after the primary care visit, a study team investigator phones each eligible patients, explains the study, and obtains verbal consent. The investigators are blinded to the randomized group status of the patients. The investigator proceeds with the interview questionnaire on consent. Age, sex is collected. Patients are asked whether the skin problem is resolved ("Is it all better?"). For every resolved problem, we ask when (date or days since visit) it was resolved. We also ask how many return visits the patient has had with any provider for that problem. If not resolved, the patient is called again at 60 days and asked the same questions. If not resolved then, we call the patient again at 90 days. The last call to any patient is at 90 days from the index visit for the problem. Data Analysis and Statistical Measures The primary predictor variable for both aims is the use of the VisualDx information source by the primary care provider. For the "days to resolution" outcome variable, the time unit (days) and the status of the problem after 90 days (resolved or not resolved) will be evaluated for each group with Kaplan-Meier survival analysis and the non-parametric log rank test of significance. For the "number of follow-up visits" outcome variable, the binary predictor (intervention group) and discrete outcome variable (number of visits) will be evaluated with Wilcoxon-rank sum test for non-normal data. The first visit of a patient to a participating provider for a skin problem is considered the index visit and that provider considered the index provider regardless of the provider seen on any subsequent appointment. Analysis will adhere to the intention-to-treat principle with group assignment determined by randomization regardless of whether VisualDx was deployed for care or not. Problems unresolved at the last contact will be censored as unresolved for the Kaplan-Meier analysis. For aim 1, the estimated sample size to detect an average difference of 8 days in time to resolution with a standard deviation of 20 and an intra-cluster correlation (ICC) of 0.025. With alpha .05 and beta .80, the study would need a minimum 26 providers enrolled with an average 10 patient participants in each provider's cluster for a total of 286 participants completing the study. We planned to enroll at least 30 providers and up to 500 patients to insure against loss to follow-up of, increased standard deviation, or larger than anticipated Intra-Cluster Correlation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Decision Support Systems,Clinical, Skin Diseases
    Keywords
    Clinical Knowledge Systems, Decision support, Dermatology, Technology Assessment

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    465 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention - VisualDx Arm
    Arm Type
    Experimental
    Arm Description
    Arm had 2 levels: provider (cluster) level and patient level. Providers, randomly assigned to the intervention arm, refer to VisualDx when they saw a patient who presented with a skin problem. Their patients were assigned to the intervention group and interviewed about the outcomes of their treatment.
    Arm Title
    Control - Usual Care Arm
    Arm Type
    No Intervention
    Arm Description
    Arm had 2 levels: provider (cluster) level and patient level. Providers, randomly assigned to control, did not refer to VisualDx but could refer to other information sources or none per usual care. Their patients were assigned to the control group and interviewed about the outcomes of their treatment
    Intervention Type
    Other
    Intervention Name(s)
    VisualDx
    Intervention Description
    VisualDx is a computerized clinical information technology with medical image and text content in dermatology.
    Primary Outcome Measure Information:
    Title
    Number of Patients With Resolved Skin Problems
    Description
    Resolved skin disease status was assessed by phone interview. Patient reported status. Patients were censored if "unresolved" at 90 days.
    Time Frame
    Period of assessment was up to 3 months (90 days) after index visit.
    Title
    Number of Follow-Up Visits to Any Provider for the Same Problem
    Description
    Follow-up visits count is assessed at each phone interview. Patients report return visits.
    Time Frame
    Period of Assessment is up to 90 days after index visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients seen by a participating Primary Care Provider for a chronic or acute skin problem Exclusion Criteria: Skin problems due to burns or lacerations Cognitively impaired, mentally ill, prisoners, non-English speaking
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marianne D Burke, PhD
    Organizational Affiliation
    University of Vermont
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Benjamin Littenberg, MD
    Organizational Affiliation
    University of Vermont
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16338914
    Citation
    Alper BS, White DS, Ge B. Physicians answer more clinical questions and change clinical decisions more often with synthesized evidence: a randomized trial in primary care. Ann Fam Med. 2005 Nov-Dec;3(6):507-13. doi: 10.1370/afm.370.
    Results Reference
    background
    PubMed Identifier
    18755999
    Citation
    Del Fiol G, Haug PJ, Cimino JJ, Narus SP, Norlin C, Mitchell JA. Effectiveness of topic-specific infobuttons: a randomized controlled trial. J Am Med Inform Assoc. 2008 Nov-Dec;15(6):752-9. doi: 10.1197/jamia.M2725. Epub 2008 Aug 28.
    Results Reference
    background
    PubMed Identifier
    23418404
    Citation
    Marshall JG, Sollenberger J, Easterby-Gannett S, Morgan LK, Klem ML, Cavanaugh SK, Oliver KB, Thompson CA, Romanosky N, Hunter S. The value of library and information services in patient care: results of a multisite study. J Med Libr Assoc. 2013 Jan;101(1):38-46. doi: 10.3163/1536-5050.101.1.007.
    Results Reference
    background
    PubMed Identifier
    22095750
    Citation
    Isaac T, Zheng J, Jha A. Use of UpToDate and outcomes in US hospitals. J Hosp Med. 2012 Feb;7(2):85-90. doi: 10.1002/jhm.944. Epub 2011 Nov 16.
    Results Reference
    background
    PubMed Identifier
    18928078
    Citation
    Awadalla F, Rosenbaum DA, Camacho F, Fleischer AB Jr, Feldman SR. Dermatologic disease in family medicine. Fam Med. 2008 Jul-Aug;40(7):507-11.
    Results Reference
    background
    PubMed Identifier
    11176657
    Citation
    Federman DG, Reid M, Feldman SR, Greenhoe J, Kirsner RS. The primary care provider and the care of skin disease: the patient's perspective. Arch Dermatol. 2001 Jan;137(1):25-9. doi: 10.1001/archderm.137.1.25.
    Results Reference
    background
    Links:
    URL
    https://www.visualdx.com/visualdx/7/
    Description
    VisualDx [Internet]. Logical Images, Inc. . Available by individual and institutional license.

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    The Impact of a Dermatology Information Source on Skin Problem Outcomes in Primary Care

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